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FDA Safety Information and Adverse Event Reporting Program

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MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program

MedWatch Online Voluntary Reporting Form (3500)

Click the BEGIN button to report serious adverse events for human medical products, including potential and actual product use errors and product quality problems associated with the use of:

  • FDA-regulated drugs,
  • biologics (including human cells, tissues, and cellular and tissue-based products)
  • medical devices (including in vitro diagnostics)
  • special nutritional products and cosmetics

A Message about Privacy

You can continue to make adverse event reports under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The HIPAA Privacy Rule is not intended to disrupt or discourage adverse event reporting in any way. In fact, the Privacy Rule specifically permits covered entities (such as pharmacists, physicians or hospitals) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.

For more information, please go to the Medwatch HIPAA Compliance page.

What NOT to Report to MedWatch Using Online Form 3500

  • Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://secure.vaers.org/VaersDataEntryintro.htm.
  • Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
  • Mandatory reporting:
    Drugs and Biologics
    Devices

Frequently Asked Questions: submitting your voluntary report online (both versions):

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